TY - JOUR
T1 - Inclusion of older adults in early-phase cancer clinical trials
T2 - safety, efficacy and a way forward
AU - Nguyen, Jessie
AU - Battisti, Nicolò Matteo Luca
AU - Ní Chróinín, Danielle
AU - Hong, Martin
AU - Nindra, Udit
AU - Hong, Jun Hee
AU - Zwieky, Walid
AU - Wilkinson, Kate
AU - Yoon, Robert
AU - Cooper, Adam
AU - Roohullah, Aflah
AU - Ng, Weng
AU - Chua, Wei
AU - Pal, Abhijit
PY - 2025/12
Y1 - 2025/12
N2 - Early-phase clinical trials (EPCTs) are critical for evaluating the safety, tolerability, efficacy and pharmacokinetics of novel oncology therapies. However, older adults are underrepresented in all phases of oncology clinical trials, including early-phase trials, creating a significant gap in evidence-based cancer management in this population, which translates into clinical practice. This is despite cancer incidence increasing with age, and a substantial proportion of cancer diagnoses occurring in individuals aged ≥ 65 years. Ageing is associated with physiological, physical and psychosocial changes which could underlie the hesitancy to include older adults in early-phase clinical trials, due to concerns of excessively compromising their safety and quality of life. However, the landscape of EPCTs has changed with higher safety and efficacy data. This review explores the current landscape of older adults in early-phase clinical trials, including the participation rate, the outcomes, and the multifaceted challenges contributing to the underrepresentation of older adults, and examines the potential strategies to enhance the inclusivity of older adults for treating older adults with cancer.
AB - Early-phase clinical trials (EPCTs) are critical for evaluating the safety, tolerability, efficacy and pharmacokinetics of novel oncology therapies. However, older adults are underrepresented in all phases of oncology clinical trials, including early-phase trials, creating a significant gap in evidence-based cancer management in this population, which translates into clinical practice. This is despite cancer incidence increasing with age, and a substantial proportion of cancer diagnoses occurring in individuals aged ≥ 65 years. Ageing is associated with physiological, physical and psychosocial changes which could underlie the hesitancy to include older adults in early-phase clinical trials, due to concerns of excessively compromising their safety and quality of life. However, the landscape of EPCTs has changed with higher safety and efficacy data. This review explores the current landscape of older adults in early-phase clinical trials, including the participation rate, the outcomes, and the multifaceted challenges contributing to the underrepresentation of older adults, and examines the potential strategies to enhance the inclusivity of older adults for treating older adults with cancer.
UR - http://www.scopus.com/inward/record.url?scp=105019503437&partnerID=8YFLogxK
UR - https://go.openathens.net/redirector/westernsydney.edu.au?url=https://doi.org/10.1007/s40266-025-01260-y
U2 - 10.1007/s40266-025-01260-y
DO - 10.1007/s40266-025-01260-y
M3 - Article
AN - SCOPUS:105019503437
SN - 1170-229X
VL - 42
SP - 1143
EP - 1158
JO - Drugs and Aging
JF - Drugs and Aging
IS - 12
ER -
